The GUARDIAN Pilot Trial

Summary

The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications (routine pressure management).

Eligibility

Inclusion Criteria:

* ≥45 years old
* Scheduled for major noncardiac surgery expected to last at least 2 hours;
* Having general endotracheal, neuraxial anesthesia, or the combination;
* Expected to require at least overnight hospitalization;
* Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
* Chronically taking at least one anti-hypertensive medication;
* Expected to have direct blood pressure monitoring with an arterial catheter;
* Cared for by clinicians willing to follow the GUARDIAN protocol;
* Subject to at least one of the following risk factors:
* History of peripheral arterial surgery;
* History of coronary artery disease;
* History of stroke or transient ischemic attack;
* Serum creatinine \>175 µmol/L (\>2.0 mg/dl);
* Diabetes requiring medication;
* Current smoking or 15 pack-year history of smoking tobacco;
* Scheduled for major vascular surgery;
* Body mass index ≥35 kg/m2;
* Preoperative high-sensitivity troponin T \>14 ng/L or troponin I equivalent;
* B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) \>100 ng/L

Exclusion Criteria:

* Are scheduled for carotid artery surgery;
* Are scheduled for intracranial surgery;
* Are scheduled for partial or complete nephrectomy;
* Are scheduled for pheochromocytoma surgery;
* Are scheduled for liver transplantation;
* Require preoperative intravenous vasoactive medications;
* Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
* Require beach-chair positioning;
* Have end-stage renal disease requiring dialysis or estimated glomerular filtration rate (eGFR) \<30 ml/min;
* Have a documented history of dementia;
* Have language, vision, or hearing impairments that may compromise cognitive assessments;
* Have contraindications to norepinephrine or phenylephrine per clinician judgement;
* Have previously participated in this trial.

Conditions2

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